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Completed

NCT Number: NCT03325985

Emergency Medicine Palliative Care Access

This is a two-arm, multi-site randomized controlled trial of 1,350 older adults (50+ years) with either advanced cancer (defined as metastatic solid tumor) or poor prognosis end-stage organ failure (New York Heart Association (NYHA) Class III or IV Congestive Heart Failure (CHF), End-Stage Renal Disease (ESRD), defined as Glomerular Filtration Rate (GFR) < 15 ml/min/m2 or dialysis ; or Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III or higher, or oxygen-dependent chronic obstructive pulmonary disease (COPD) who present to the Emergency Department (ED), along with 675 of their informal caregivers. Investigators will compare the effectiveness of two distinct palliative care models: a) nurse-led telephonic case management; and b) facilitated, outpatient specialty palliative care.

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Key information

Conditions

Advanced Cancer End Stage Organ Failure

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles Ronald Reagan Medical Center, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients:

  • English or Spanish-speaking patients ages 50 years and older
  • Qualifying serious, life-limiting conditions and who are scheduled for ED discharge, observation status, or admission for two midnights or less.
  • Qualifying conditions include: advanced cancer (defined as metastatic solid tumor) or poor prognosis end-stage organ failure New York Heart Association (NYHA) Class III or IV Congestive Heart Failure (CHF), End-Stage Renal Disease (ESRD), defined as Glomerular Filtration Rate (GFR) < 15 ml/min/m2 or dialysis; or Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III or higher or stage III or IV, or oxygen-dependent chronic obstructive pulmonary disease (COPD) defined as Global Initiative for Chronic Obstructive Lung Disease (GOLD)
  • Patients must have health insurance, reside within the geographical area, and have a working telephone.

Informal Caregivers:

  • English or Spanish-speaking primary caregivers (relative or friend who has contact with the patient at least two times per week) ages 18 years and older.

Exclusion criteria

  • Patients with dementia identified in the EHR, who received hospice services in the last six months, who have received 2 or more palliative care visits in the last 6 months, and those who reside in a skilled nursing or assisted living facility, or chronic care hospital.

Treatment and study plan

Nurse-led telephonic case management

Behavioral

Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.

Facilitated,outpatient specialty palliative care

Behavioral

In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.

Primary outcomes

  1. Change in Quality of Life for Patients, as Measured by the Functional Assessment of Cancer Therapy - General (FACT-G)

    Time frame: Baseline, Month 6

    • Measured by change from enrollment to 6 months
    • Used to measure a person's quality of life
    • 27 questions total
    • 5-point Likert scale
    • Reverse code select items per scoring guidelines at facit.org, then calculate a summary score for each respondent. The total score ranges from 0-108 points; higher scores indicate greater quality of life.

Secondary outcomes

  1. Number of Emergency Department (ED) Revisits

    Time frame: Up to Month 12

    Measured from enrollment to 12 months as a count of ED revisits, via self-report and EHR abstraction.

  2. Number of Inpatient Days

    Time frame: Up to Month 12

    Measured from enrollment to 12 months as the number of inpatient days, via self-report and EHR extraction.

  3. Proportion of Participants Who Used Hospice

    Time frame: Up to Month 12

    Measured from enrollment to 12 months as the proportion of participants who used hospice, via self-report and EHR abstraction.

  4. Change in Loneliness, as Measured by the Three-Item Loneliness Scale

    Time frame: Baseline, Month 3

    • Used to measure how often a person feels disconnected from others
    • Three questions total
    • 3-point rating scale (1 = Hardly ever, 2 = Some of the time, 3 = Often)
    • Total score is the sum of responses and ranges from 3 to 9; higher scores indicate greater loneliness.
    • measured by change from enrollment to 3 months

  5. Change in Loneliness, as Measured by the Three-Item Loneliness Scale

    Time frame: Baseline, Month 6

    • Used to measure how often a person feels disconnected from others
    • Three questions total
    • 3-point rating scale (1 = Hardly ever, 2 = Some of the time, 3 = Often)
    • Total score is the sum of responses and ranges from 3 to 9; higher scores indicate greater loneliness.
    • measured by change from enrollment to 6 months

  6. Change in Loneliness, as Measured by the Three-Item Loneliness Scale

    Time frame: Baseline, Month 12

    • Used to measure how often a person feels disconnected from others
    • Three questions total
    • 3-point rating scale (1 = Hardly ever, 2 = Some of the time, 3 = Often)
    • Total score is the sum of responses and ranges from 3 to 9; higher scores indicate greater loneliness.
    • measured by change from enrollment to 12 months

  7. Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)

    Time frame: Baseline, Month 3

    • Used to measure severity of symptoms
    • 10 questions
    • Each item is rated on a 0-10 scale (0= none to 10 worst possible)
    • Total score ranges from 0 to 100; higher scores indicate greater severity of symptoms.
    • measured by change from enrollment to 3 months

  8. Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)

    Time frame: Baseline, Month 6

    • Used to measure severity of symptoms
    • 10 questions
    • Each item is rated on a 0-10 scale (0= none to 10 worst possible)
    • Total score ranges from 0 to 100; higher scores indicate greater severity of symptoms.
    • measured by change from enrollment to 6 months

  9. Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)

    Time frame: Baseline, Month 12

    • Used to measure severity of symptoms
    • 10 questions
    • Each item is rated on a 0-10 scale (0= none to 10 worst possible)
    • Total score ranges from 0 to 100; higher scores indicate greater severity of symptoms.
    • measured by change from enrollment to 12 months

  10. Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)

    Time frame: Baseline, Month 3

    • Quality of life for informal caregivers will be measured using the 10-item Patient-Reported Outcome Measurement Information System (PROMIS-10), an instrument designed to measure perceptions of health using global health items. It contains a global physical health scale and a global mental health scale.
    • Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning.
    • measured by change from enrollment to 3 months

  11. Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)

    Time frame: Baseline, Month 6

    • Quality of life for informal caregivers will be measured using the 10-item Patient-Reported Outcome Measurement Information System (PROMIS-10), an instrument designed to measure perceptions of health using global health items. It contains a global physical health scale and a global mental health scale.
    • Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning.
    • measured by change from enrollment to 6 months

  12. Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)

    Time frame: Baseline, Month 12

    • Quality of life for informal caregivers will be measured using the 10-item Patient-Reported Outcome Measurement Information System (PROMIS-10), an instrument designed to measure perceptions of health using global health items. It contains a global physical health scale and a global mental health scale.
    • Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning.
    • measured by change from enrollment to 12 months

  13. Caregiver Bereavement, as Measured by the Texas Inventory of Grief

    Time frame: 3 Months Post-Patient Death

    • Measured at 3 months post-patient death
    • Used to measure a caregiver's bereavement
    • 19 items; each rated on a 5-point scale from 0 (never) to 4 (always)
    • Total score is the sum of responses and ranges from 0 to 76; higher scores indicate greater levels of grief

  14. Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)

    Time frame: Baseline, Month 3

    • Measured as change from enrollment to Month 3
    • Used to measure a caregiver's strain
    • 12 items; each rated on a 3-point scale from 0 (yes, on a regular basis) to 3 (no)
    • Total score is the sum of responses and ranges from 0 to 48; higher scores indicate greater burden

  15. Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)

    Time frame: Baseline, Month 6

    • Measured as change from enrollment to Month 6
    • Used to measure a caregiver's strain
    • 12 items; each rated on a 3-point scale from 0 (yes, on a regular basis) to 3 (no)
    • Total score is the sum of responses and ranges from 0 to 48; higher scores indicate greater burden

  16. Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)

    Time frame: Baseline, Month 12

    • Measured as change from enrollment to Month 12
    • Used to measure a caregiver's strain
    • 12 items; each rated on a 3-point scale from 0 (yes, on a regular basis) to 3 (no)
    • Total score is the sum of responses and ranges from 0 to 48; higher scores indicate greater burden

  17. Change in Quality of Life for Patients, as Measured by the FACT-G

    Time frame: Baseline, Month 3

    • Measured by change from enrollment to 3 months
    • Used to measure a person's quality of life
    • 27 questions total
    • 5-point Likert scale
    • Reverse code select items per scoring guidelines at facit.org, then calculate a summary score for each respondent. The total score ranges from 0-108 points; higher scores indicate greater quality of life.

  18. Change in Quality of Life for Patients, as Measured by the FACT-G

    Time frame: Baseline, Month 12

    • Measured by change from enrollment to 12 months
    • Used to measure a person's quality of life
    • 27 questions total
    • 5-point Likert scale
    • Reverse code select items per scoring guidelines at facit.org, then calculate a summary score for each respondent. The total score ranges from 0-108 points; higher scores indicate greater quality of life.

  19. Change in Caregiver Mental Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)

    Time frame: Baseline, Month 3

    • Quality of life for informal caregivers will be measured using the 10-item Patient-Reported Outcome Measurement Information System (PROMIS-10), an instrument designed to measure perceptions of health using global health items. It contains a global physical health scale and a global mental health scale.
    • Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning.
    • Measured by change from enrollment to 3 months

  20. Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)

    Time frame: Baseline, Month 6

    • Quality of life for informal caregivers will be measured using the 10-item Patient-Reported Outcome Measurement Information System (PROMIS-10), an instrument designed to measure perceptions of health using global health items. It contains a global physical health scale and a global mental health scale.
    • Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning.
    • Measured by change from enrollment to 6 months

  21. Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)

    Time frame: Baseline, Month 12

    • Quality of life for informal caregivers will be measured using the 10-item Patient-Reported Outcome Measurement Information System (PROMIS-10), an instrument designed to measure perceptions of health using global health items. It contains a global physical health scale and a global mental health scale.
    • Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning.
    • Measured by change from enrollment to 6 months

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Atlantic Health System
  • Beaumont Health
  • Dana-Farber/Brigham and Women's Cancer Center
  • Hackensack Meridian Health
  • Henry Ford Health System
  • Northwestern University
  • Ohio State University
  • Patient-Centered Outcomes Research Institute
  • Rush University
  • University of California, Irvine
  • University of California, Los Angeles
  • University of California, San Diego
  • University of Florida
  • Yale University

Registry information

Official study title

Emergency Medicine Palliative Care Access (EMPallA)

Acronym: EMPallA

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Oct 30, 2017
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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